RITUXIMAB CIPLA can have side effects. Not all side effects reported for RITUXIMAB CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving RITUXIMAB CIPLA, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop receiving RITUXIMAB CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
- Rash or itching,
- Fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to RITUXIMAB CIPLA. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Chest pain,
- Angina,
- Changes in the way your heart beats e.g. if you notice it beating faster,
- Difficulty in breathing,
- Less urine than is normal for you,
- Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.
These are all serious side effects. You may need medical attention.
Infusion reactions
During or within the first 2 hours of the first infusion you may develop fever, chills and shivering. Less frequently, some patients may experience blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy, runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these might get worse. Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped for a while. You may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away, or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. Your doctor may decide not to continue with RITUXIMAB CIPLA treatment if you have a serious infusion-related reaction.
Infections
Tell your doctor after your RITUXIMAB CIPLA treatment if you get any symptoms of an infection, for example fever, cough, sore throat, burning pain when passing urine, or you start to feel weak or generally unwell. You might get infections more easily following RITUXIMAB CIPLA therapy. Often these are colds, but there have been cases of pneumonia or urinary infections. There have been patients being treated with RITUXIMAB CIPLA who had experienced a serious brain infection, which was fatal. Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
Skin Reactions
Severe blistering skin conditions that can be life-threatening have occurred, including Stevens-Johnson Syndrome. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms.
Other reactions
a) If you are being treated for non-Hodgkin’s Lymphoma or chronic lymphocytic leukaemia
The following side effects have frequently been reported:
- Infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation (bronchitis),
- Low number of white blood cells, with or without fever, low number of platelets in the blood,
- Allergic reactions after infusion,
- Skin rashes, itching, bald spots on the scalp, fever, chills, physical weakness, headache,
- Infections such as sepsis and pneumonia (bacterial), herpes and hepatitis B (viral) or candidal (fungal) bronchial tube and sinuses inflammation, or other general infections of unknown origin’,
- Low number of red blood cells, low number of red and white blood cells and platelets,
- Allergic reactions (hypersensitivity),
- High sugar level in the blood, weight loss, excess fluid in the face and the body, increased blood levels of the enzyme (LDH), low blood level of calcium,
- Abnormal sensations of the skin, such as numbness, tingling, pricking, burning, a creeping skin sensation, decreased sense of touch. Feeling restless, difficulty falling asleep, becoming red in the face and bruising of the skin as a consequence of dilation of the blood vessels, dizziness, anxiety,
- An increased production of tears, secretion and shedding disorders, inflammation of the eye (conjunctivitis),
- Ringing sound in the ears, ear pain,
- Heart disorders (heart attack, irregular heart rate, abnormally fast heart rate),
- High or low blood pressure, a decrease in blood pressure upon assuming an upright posture,
- Inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of breath, too little oxygen reaching the body organs, coughing,
- Vomiting, diarrhoea, pain in the abdomen, irritation and /or ulceration of the throat and the mouth, difficulties in swallowing, constipation, indigestion. Eating disorders: decrease in the amount of food eaten with a consequential dangerous loss in weight,
- Skin disorders, burning sensation of the skin, itching, increased perspiration, night sweats,
- Musculoskeletal disorders, abnormal increase in tightness of muscle tone, pain, joint pain, muscle pain, back and neck pain,
- General disorders, tumour pain, becoming markedly red in the face and other areas of the skin, general discomfort or uneasiness, flu syndrome, fatigue, shaking, multi-organ dysfunction.
The following side effects have been reported less frequently:
- Abnormal clotting, decrease of blood cells production, auto-immune decrease of red blood cells, swollen/enlarged lymph nodes,
- Low mood and loss of interest or pleasure in usual activities, nervousness,
- Taste changes,
- Heart disorder (heart attack, abnormal fast heart rate, reduced heart rate, irregular heart rate, chest pain) inflammation, irritation and/or tightness of the lungs, asthma, shortness of breath,
- Enlargement of the abdomen,
- Pain at the infusion site,
- Temporary increased immunoglobulins, chemical disturbances in blood caused by the breakdown of dying cancer cells, which can also lead to kidney failure,
- Nerve damage in arms and legs, paralysis of the face,
- Heart failure,
- Inflammation of blood vessels including those leading to skin symptoms,
- Perforation of the bowel wall,
- Kidney failure,
- Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present,
- Infection caused by a fungus called Pneumocystis jirovecii.
The following side effects have been reported with unknown frequency:
- Delayed reduction of white blood cells,
- Infusion-related immediate reduction of platelets (reversible), can be fatal in rare cases,
- Hearing loss,
- Loss of other senses.
Children and adolescents with non-Hodgkin’s lymphoma: In general, side effects in children and adolescents with non-Hodgkin’s lymphoma were similar to those in adults with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia. The most frequent side effects seen were fever associated with low levels of a type of white blood cell (neutrophil), inflammation or sores in the lining of the mouth, and allergic reactions (hypersensitivity).
b) If you are being treated for rheumatoid arthritis
The following side effects have frequently been reported:
- Infections such as pneumonia (bacterial),
- Pain on passing water (urinary tract infection),
- Allergic reactions that are most likely to occur during an infusion, but can occur up to 24- hours after infusion,
- Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or block nose and sneezing, shaking, rapid heart-beat, and tiredness,
- Headache,
- Changes in laboratory tests carried out by your doctor. These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection,
- Infections such as bronchial tube inflammation (bronchitis),
- A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems,
- Fungal foot infection (athlete’s foot),
- High cholesterol levels in the blood,
- Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, migraine, dizziness,
- Loss of hair,
- Anxiety, depression,
- Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth,
- Pain in the tummy, back, muscles and/or joints.
The following side effects have been reported less frequently:
- Excess fluid retention in the face and body,
- Inflammation, irritation and / or tightness of the lungs, and throat, coughing,
- Skin reactions including hives, itching and rash,
- Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse,
- A complex of symptoms occurring within a few weeks of an infusion of rituximab including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever,
- Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Other reported side effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection. Some infections may be severe (please see information on Infections within this section).
c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
The following side effects have frequently been reported:
- Infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections,
- Allergic reactions that are most likely to occur during an infusion, but can occur up-to 24- hours after infusion,
- Diarrhoea,
- Coughing or shortness of breath,
- Nose bleeds,
- Raised blood pressure,
- Painful joints or back,
- Muscle twitches or shakiness,
- Feeling dizzy,
- Tremors (shakiness, often in the hands),
- Difficulty sleeping (insomnia),
- Swelling of the hands or ankles,
- Indigestion,
- Constipation,
- Skin rashes, including acne or spots,
- Flushing or redness of the skin,
- Blocked nose,
- Tight or painful muscles,
- Pain in the muscles or in the hands or feet,
- Low number of red blood cells (anaemia),
- Low numbers of platelets in the blood,
- An increase in the amount of potassium in the blood,
- Changes in the rhythm of the heart, or the heart beating faster than normal.
The following side effects have been reported less frequently:
- Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present,
- Recurrence of a previous Hepatitis B infection.
Children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis: In general, side effects in children and adolescents with granulomatosis with polyangiitis or microscopic polyangiitis were of a similar type to those in adults with granulomatosis with polyangiitis or microscopic polyangiitis. Most common side effects seen were infections, allergic reactions and feeling sick (nausea).
